Inspiratory Muscle Training in Lung Transplant Candidates

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

Recovery after lung transplantation (LTx) may be complicated by prolonged mechanical ventilation (MV) and protracted intensive care unit (ICU) stay leading to immobilization and impaired health-related quality of life (HRQoL). In the critical care setting, diaphragm atrophy and weakness have been associated with difficulty weaning from MV, increased risk for readmission to hospital or ICU, and increased mortality. Increasing respiratory muscle strength by inspiratory muscle training (IMT) as part of pre-rehabilitation mitigates respiratory muscle dysfunction peri-operatively and may reduce the risk of post-operative complications. However, IMT is not widely used prior to LTx and the benefits of pre-operative IMT on post-transplant outcomes in LTx candidates have not been studied. Objectives: (1) To evaluate the feasibility of a multicenter randomized clinical trial of IMT in LTx candidates in terms of recruitment rate, retention, program adherence, and outcome ascertainment; (2) To establish the change in pre-transplant dyspnea perception, diaphragm structure and function, health related quality of life (HRQoL) and post-transplant intensive care unit (ICU), hospital and post-transplant 3-month outcomes with IMT relative to usual care group; and (3) To characterize the effect of pre-transplant IMT on peri-transplant diaphragm myofibrillar cross-sectional area (CSA), oxidative capacity, inflammatory markers and post-transplant diaphragm muscle thickness and function (UHN TGH site).

Eligibility criteria

Qualifiers

Adult participants (≥ 18 years of age)

Lung Transplant Candidates

Participating in outpatient pulmonary rehabilitation (standard of care)

Diagnosis of Interstitial Lung Disease or Chronic Obstructive Pulmonary Disease

Disqualifiers

Respiratory exacerbation within the last 1 month

Neurologic or musculoskeletal conditions that may interfere with IMT or functional assessments (i.e. history of stroke, severe arthritis of hands)

Insufficient English fluency to provide informed consent or to follow study protocols

Any evidence of pneumothorax on recent imaging (< 6 months)

Trial design

Treatments tested in this trial

  • IMT and exercise training group

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Health Network, Toronto

Lead sponsor

Canadian National Transplant Research Program

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

Ozmosis Research Inc.

Collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Vancouver General Hospital

Collaborator